![\"\"](\"https:\/\/www.veeva.com\/wp-content\/uploads\/2021\/12\/Advanced-Clinical-Achieves.png\")
<\/p>\n\nContract research organization leverages cloud solution
\nto run faster, higher-quality trials for study partners\n<\/p>\n
<\/p>\n
\nAdvanced Clinical is a full-service, global contract research organization,
\nsupporting Phase I-IV clinical trials across all major therapeutic areas. In
\norder to strengthen their position as a trusted partner in clinical trials and
\nresearch, Advanced Clinical prioritized modernizing their clinical operations
\nenvironment to increase the speed and quality of their clinical trials.\n<\/p>\n
\nAdvanced Clinical previously used paper to manage trial master file
\ndocumentation. This time and resource-intensive method impacted internal
\nand external collaboration. It hindered visibility and oversight of the current
\ntrial status, making it challenging to draw real-time insights to proactively
\nsteer trials. This ultimately impacted their ability to achieve ongoing
\ncompliance and inspection readiness.\n<\/p>\n
\n\u201cVisibility to clinical documents was essentially limited to an office-based archive room,\u201d said JP Miceli, associate
\ndirector of document management at Advanced Clinical. \u201cWhile we had trackers on what was in the TMF, we couldn\u2019t
\neasily verify its accuracy.\u201d\n<\/p>\n
\nWhile researching an automated solution to address these challenges, Advanced Clinical discovered many solutions
\nwere built on dated infrastructures which would not be able to keep pace with business change and growth.\n<\/p>\n
\nAdvanced Clinical recognized the need to move from paper to a modern, purpose-built eTMF solution to increase
\nspeed and quality of trials while driving visibility and oversight for sponsors.\n<\/p>\n
\nAdvanced Clinical selected Veeva eTMF to deliver eTMF services in the cloud. \u201cWe wanted a truly innovative system so
\nwe could define our business processes and ensure alignment with our configuration. Above all, we wanted to be able
\nto deliver clinical trials faster, better, and more reliably for our sponsors,\u201d said Miceli.\n<\/p>\n
\n\u201cVeeva eTMF allows us to produce meaningful metrics \u2013 through easy-to-use, intuitive dashboards and reporting \u2013 and
\nconsistently offer our clients the control, transparency, and visibility they want.\u201d\n<\/p>\n
\nVeeva eTMF has enabled Advanced Clinical to streamline its processes, improve compliance and collaboration, and
\ndeliver higher-quality trials for sponsors.\n<\/p>\n
\nFrom outlining document filing processes to implementing best practices for managing document quality, adhering to
\npre-defined KPIs enables Advanced Clinical to demonstrate improved trial conduct. This discipline ensures the team
\nhas early visibility into issues, allowing them to avoid blind spots in document management.\n<\/p>\n
\nVeeva eTMF enables Advanced Clinical to offer the trial visibility stakeholders require. Reports and dashboards provide
\na view of overall trial progress alongside specific information on key TMF health metrics, like accuracy, completeness,
\nand timeliness. Advanced Clinical retains control of the eTMF, giving sponsors access to the level of information they
\nrequire. For example, sponsors may want to see final, approved documents and real-time reports, which can be
\ndelivered through reliable dashboards.\n<\/p>\n
\nVault eTMF offers cross-functional teams access to a shared, authoritative location for documentation. This drives
\ncollaboration, ensuring stakeholders use the solution as more than a static repository.\n<\/p>\n
\nIt also enables Advanced Clinical to streamline existing document management processes. For example, data
\nmanagers can now upload safety data listings into Vault and route to medical monitors for feedback, through a
\npre-defined authoring workflow. They can respond within the system, alerting data managers to act and send the
\neTMF record for quality control (QC) review in real-time.\n<\/p>\n
\nWhen it comes to QC, Veeva eTMF functionality is helping to reduce the number of rejected documents.\n<\/p>\n
\n\u201cWe\u2019re excited to use quality issue objects. To have object life cycles on it, that\u2019s a seismic change. Otherwise, we
\nlack the visibility into why documents were rejected, and it is hard to go and fix, or to reduce the number of rejected
\ndocuments. It\u2019s a major improvement,\u201d added Miceli.\n<\/p>\n
In 2022, Advanced Clinical adopted the Veeva TMF Bot, which uses artificial intelligence to streamline TMF management and automate document classification. The TMF Bot helps Advanced Clinical improve inspection readiness by reducing time spent on manual tasks as well as human error in the documentation process. This has directly contributed to greater speed, better accuracy, and improved quality throughout the document lifecycle. <\/p>\n
\u201cWhen the system can automatically classify documents for you, it drastically reduces the number of times a person has to go in and figure that out for themselves,\u201d said Miceli. \u201cWithout having to manually assign a classification, the document management team processes documents approximately 30% faster. That is invaluable.\u201d<\/p>\n
\nUsing Veeva eTMF enabled Advanced Clinical to dramatically reduce costs around document exchange. Uploading
\ndocuments directly to Veeva eTMF reduced TMF submission time by eliminating transmittal forms and courier shipments.\n<\/p>\n
\n\u201cPreviously, there was a risk and cost to transport documents from the field to the TMF. Choosing to upload documents
\ndirectly took away that concern and made it easier to identify any document issues,\u201d said Miceli.\n<\/p>\n
\nSince implementing Veeva eTMF, Advanced Clinical has supported and facilitated successful client, mock, and internal
\naudits in Veeva eTMF as well as agency inspections by MHRA and the FDA.\n<\/p>\n
\n\u201cWe have close visibility to auditors\u2019 actions taken in the system and leverage the system logs to generate daily
\nsummaries of all records that are viewed or downloaded,\u201d added Miceli.\n<\/p>\n
\n\u201cOur filing oversight procedures measure quality and performance to compel continuous inspection readiness which
\neases pre-inspection stress and eliminates the chaotic filing we\u2019ve all seen in the past.\u201d\n<\/p>\n
\nMoving to a purpose-built eTMF has enabled Advanced Clinical to deliver faster, higher-quality trials for study sponsors.
\nIt has replaced time and resource-intensive manual processes, streamlined collaboration, and boosted visibility and
\noversight for study partners.\n<\/p>\n
\n\u201cVeev eTMF gives us and our partners a strategic advantage. We can speed document collection, from startup through
\ntrial close, while enabling anytime-anywhere access and visibility for study partners throughout the entire study,\u201d
\nsaid Miceli.\n<\/p>\n
\n\u201cIt has enabled us to conduct faster, higher-quality trials and ultimately enabled us to drive an engaged culture of
\nongoing inspection readiness.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"
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